High-Fermented Food Intervention Among Locally Advanced Rectal Cancer Patients (The FEED Trial) (NCT06337552) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
High-Fermented Food Intervention Among Locally Advanced Rectal Cancer Patients (The FEED Trial)
United States39 participantsStarted 2024-04-04
Plain-language summary
The purpose of the study is to evaluate the feasibility and acceptability of a dietary intervention (FEED-FF) that includes fermented foods (FF), among locally advanced rectal cancer patients and non-small cell lung cancer (NSCLC) patients, and to explore whether this diet can improve outcomes in rectal cancer patients receiving chemoradiation and NSCLC patients receiving immunotherapy.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria for GI Patients:
* 18 years of age or older
* Diagnosed with locally advanced rectal cancer (Stage II-III)
* Will undergo neoadjuvant chemoradiation at Moffitt Cancer Center
* Able to pick up FFs once/weekly at Moffitt
* Able to speak and read English
* Able to consume foods orally
* Able to provide informed consent
Inclusion Criteria for Thoracic Patients:
* 18 years of age or older
* Diagnosed with stage II-IV non-small cell lung cancer (NSCLC)
* Will undergo Immunotherapy with immune checkpoint inhibitors (+/- chemotherapy or other treatment) at Moffitt Cancer Center
* Able to pick up FFs once/weekly at Moffitt
* Able to speak and read English
* Able to consume foods orally
* Able to provide informed consent
Exclusion Criteria:
* Antibiotic use within 1 month prior to baseline
* If currently using probiotics, unwillingness to cease probiotic use
* Previous receipt of surgery, immunotherapy, chemotherapy, or radiation for a colon or rectal tumor
* Per clinician's discretion, clinician confirmed inflammatory bowel conditions (e.g., ulcerative colitis, Crohn's disease)
* Infectious disease diagnosed \<1 month prior to baseline
* Already consuming ≥2 servings of fermented foods/day
* Previously diagnosed with a mast cell disorder or histamine allergy
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Effects of the FEED-FF diet on clinical response to chemoradiation (Rectal Cancer Patients)
Timeframe: At Baseline and Up to 12.5 Weeks
2
Effects of the FEED-FF diet on clinical response to immunotherapy (Lung Cancer Patients)
Timeframe: At Baseline and Up to 12.5 Weeks
3
Effects of FEED-FF diet on the gut microbiome
Timeframe: At Baseline, Week 6.5 and Up to 12.5 Weeks
4
Effects of FEED-FF diet on local immune-related biomarkers
Timeframe: At Baseline and Up to 12.5 Weeks
5
Effects of FEED-FF diet on quality of life
Timeframe: At Baseline, Week 6.5 and Up to 12.5 Weeks
6
Efficacy of the FEED-FF intervention
Timeframe: At Baseline, Week 6.5 and Up to 12.5 Weeks
7
Feasibility of the FEED-FF intervention
Timeframe: At Baseline, Week 6.5 and Up to 12.5 Weeks
Trial details
NCT IDNCT06337552
SponsorH. Lee Moffitt Cancer Center and Research Institute